Full Press Release Details
Can-Fite Reports 2022 Financial Results & Provides Clinical Update
PETACH TIKVA, Israel, March 30, 2023 -- Can-Fite BioPharma
Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address
inflammatory, cancer and liver diseases, today announced financial results for the year ended December 31, 2022.
2022 & Recent Corporate and Clinical Development
Phase III COMFORT Psoriasis Trial Met
Primary Endpoint - Patients receiving Piclidenoson 3mg demonstrated a statistically significant improvement when compared with
placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response at week 16 of treatment. An excellent safety profile
Pivotal Phase III Psoriasis Registration Plan
for Piclidenoson Submitted to EMA - Can-Fite submitted a market registration plan to the European Medicines Agency (EMA) for
Piclidenoson in the treatment of moderate to severe psoriasis. A submission to the U.S. Food and Drug Administration (FDA) will follow.
Developing Piclidenoson as a Topical Psoriasis
Treatment - In a preclinical model, daily treatment with topical Piclidenoson significantly inhibited psoriasis as measured
by PASI calculated based on observation of erythema, thickness, scaling, and a score of skin lesions. The topical treatment may serve
as a complementary product to oral Piclidenoson.
Piclidenoson Advances as a Treatment for Osteoarthritis
in Dogs - Vetbiolix, Can-Fite's veterinary commercialization partner, achieved progress in the development of Piclidenoson
for the canine osteoarthritis market projected to reach $3 billion by 2028. Vetbiolix is covering all costs associated with veterinary
clinical development.
Namodenoson Found to Significantly Inhibit
Pancreatic Cancer in Preclinical Studies - Namodenoson was found to have a significant anti-cancer effect in pancreatic carcinoma
as a monotherapy, as well as an additive effect when combined with gemcitabine, the standard-of-care chemotherapy for pancreatic cancer.
Namodenoson's excellent safety profile and its ability to directly inhibit the growth of pancreatic tumors present its potential
as an effective drug for the treatment of this disease which has a 5-year survival rate of only 11% in the U.S. Can-Fite has filed a patent
application that covers the use of Namodenoson for the treatment of pancreatic cancer.
The U.S. Patent and Trademark Office Granted
Can-Fite a Patent for the Treatment of Liver Fibrosis - The invention titled "Method for Treating Fibrotic Liver Tissue
Using CL-IB MECA" is a broad patent that addresses markets for the treatment of all advanced liver fibrosis indications. The patent
opens an opportunity for much broader market needs which entail all clinical conditions with advanced liver fibrosis.
Ongoing Advanced Clinical Studies with Namodenoson:
Following Complete Response in a Patient with
Advanced Liver Cancer Treated with Namodenoson:
"With two Phase III indications advancing
through our pipeline, we look ahead to the potential commercialization of our small molecule drugs, Piclidenoson and Namodenoson,"
stated Can-Fite CEO Dr. Pnina Fishman. "Namodenoson in particular is showing the potential for efficacy across several indications
from liver disease to pancreatic cancer. We remain focused and committed to bringing our safe, oral drugs to patients with unmet needs."
Revenues for the year ended December 31, 2022
were $0.81 million, a decrease of $0.04 million, or 4.7%, compared to revenues of $0.85 million during the twelve months ended December
31, 2021. The decrease is considered to be not material.
Research and development expenses for the year
ended December 31, 2022 were $7.76 million, a decrease of $2.09 million, or 21.2%, compared to $9.85 million for the year ended December
31, 2021. Research and development expenses for the year ended December 31, 2022 comprised primarily of expenses associated with the completion
of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the
treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to the wrap up of the Phase III study
of Piclidenoson for the treatment of psoriasis in 2022.
General and administrative expenses were $3.14
million for the year ended December 31, 2022, a decrease of $0.70 million, or 18.2%, compared to $3.84 million for the same period in
2021. The decrease is primarily due to the decrease in professional services and public and investor relations expenses. We expect general
and administrative expenses will remain at the same level for 2023 and beyond.
Financial expense, net for the year ended December
31, 2022 was $0.07 million compared to financial income, net of $0.22 million for the same period in 2021. The decrease in financial income,
net was mainly due to an increase in revaluation of our short-term investments which was offset by an increase in interest from short
Can-Fite's net loss for the year ended December
31, 2022 was $10.17 million compared with a net loss of $12.61 million for the same period in 2021. The decrease in net loss was primarily
attributable to a decrease in research and development expenses and a decrease in general and administrative expenses.
As of December 31, 2022, Can-Fite had cash, cash
equivalents, and short-term deposits of $7.97 million as compared to $18.90 million at December 31, 2021. The decrease in cash during
the year ended December 31, 2022 is due to Company's operating activity. During January 2023, the Company raised approximately $6.80
The Company's consolidated financial results for
the twelve months ended December 31, 2022 are presented in accordance with US GAAP Reporting Standards.
More detailed information can be found in the
Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2022, a copy of which has been filed with the Securities
and Exchange Commission (SEC). The Annual Report, which contains the Company's audited consolidated financial statements, can be
accessed on the SEC's website at http://www.sec.gov/ as well as via the Company's investor relations website at https://ir.canfite.com.
The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge,
to its shareholders upon request to Can-Fite Investor Relations at 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778, Israel or by
phone at +972-3-9241114.
U.S dollars in thousands (except for share
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 2,978 | $ | 4,390 | ||||
| Short-term deposits | 5,001 | 14,512 | ||||||
| Prepaid expenses, and other current assets | 1,170 | 929 | ||||||
| Short-term investment | 8 | 237 | ||||||
| Total current assets | 9,157 | 20,068 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Operating lease right of use assets | 84 | 138 | ||||||
| Property, plant and equipment, net | 42 | 47 | ||||||
| Total non-current assets | 126 | 185 | ||||||
| Total assets | $ | 9,283 | $ | 20,253 |
U.S dollars in thousands (except for share and per share data)
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 896 | $ | 954 | ||||
| Current maturity of operating lease liability | 48 | 53 | ||||||
| Deferred revenues | 783 | 818 | ||||||
| Other accounts payable | 775 | 905 | ||||||
| Total current liabilities | 2,502 | 2,730 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Long-term operating lease liability | 14 | 71 | ||||||
| Deferred revenues | 2,295 | 3,070 | ||||||
| Total non-current liabilities | 2,309 | 3,141 | ||||||
| CONTIGENT LIABILITIES AND COMMITMENTS | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares of no par value - Authorized: 5,000,000,000 shares at December 31, 2022 and 2021; Issued and outstanding: 815,746,293 shares as of December 31, 2022 and 2021 | - | - | ||||||
| Additional paid-in capital | 154,192 | 153,929 | ||||||
| Accumulated other comprehensive income | 1,127 | 1,127 | ||||||
| Accumulated deficit | (150,847 | ) | (140,674 | ) | ||||
| Total shareholders' equity | 4,472 | 14,382 | ||||||
| Total liabilities and shareholders' equity | $ | 9,283 | $ | 20,253 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
U.S dollars in thousands (except for share and per share data)
| Year ended December 31, | ||||||||||||
| 2022 | 2021 | 2020 | ||||||||||
| Revenues | $ | 810 | $ | 853 | $ | 763 | ||||||
| Research and development expenses | (7,763 | ) | (9,850 | ) | (11,951 | ) | ||||||
| General and administrative expenses | (3,143 | ) | (3,845 | ) | (2,951 | ) | ||||||
| Operating loss | (10,096 | ) | (12,842 | ) | (14,139 | ) | ||||||
| Total financial income (expense), net | (77 | ) | 227 | (304 | ) | |||||||
| Loss before taxes on income | (10,173 | ) | (12,615 | ) | (14,443 | ) | ||||||
| Taxes on income | - | - | - | |||||||||
| Net loss | $ | (10,173 | ) | $ | (12,615 | ) | $ | (14,443 | ) | |||
| Deemed dividend | - | (2,590 | ) | (715 | ) | |||||||
| Total comprehensive loss | $ | (10,173 | ) | $ | (15,205 | ) | $ | (15,158 | ) | |||
| Basic and diluted net loss per share | $ | (0.01 | ) | $ | (0.03 | ) | $ | (0.04 | ) | |||
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 815,746,293 | 553,079,638 | 358,411,297 |
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF)
(TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion
dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported
topline results in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the
treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma
(HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track
Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to
potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy
in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical
studies to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking
statements, about Can-Fite's expectations, beliefs or intentions regarding, among other things, its product development efforts,
business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those
relating to historical facts, are "forward looking statements". Forward-looking statements can be identified by the use of
forward-looking words such as "believe," "expect," "intend," "plan," "may,"
"should" or "anticipate" or their negatives or other variations of these words or other comparable words or by
the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated
or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that
have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause
Can-Fite's actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements
to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and
needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties
of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical